An Open-label, Single-sequence Study to Investigate the Effects of Cytochrome P450 1A2 Induction by Ritonavir on the Pharmacokinetics of BMS-986165 in Healthy Participants
A Study to Investigate the Effects of Cytochrome P450 1A2 Induction by Ritonavir on BMS-986165 Drug Levels and Effects in Healthy Participants
Sponsors
Source
Bristol-Myers Squibb
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
Yes
Is Fda Regulated Device
No
Brief Summary
The Study of Cytochrome P450 1A2 Induction by Ritonavir on the drug effects of BMS-986165 in
Healthy Participants
Overall Status
Completed
Start Date
2019-08-07
Completion Date
2019-09-21
Primary Completion Date
2019-09-21
Phase
Phase 1
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Maximum observed plasma concentration (Cmax) of BMS-986165 |
Day 1 |
|
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration of BMS-986165 |
Day 1 |
|
Area under the plasma concentration-time curve from time zero extrapolated to infinite time in BMS-986165 |
Day 1 |
|
Maximum observed plasma concentration of BMS-986165 in combination with steady-state ritonavir |
Day 15 |
|
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration of BMS-986165 in combination with steady-state ritonavir |
Day 15 |
|
Area under the plasma concentration-time curve from time zero extrapolated to infinite time in BMS-986165 in combination with steady-state ritonavir |
Day 15 |
Secondary Outcome
Measure |
Time Frame |
|
Incidence of Adverse Events (AEs) |
initial dose up to day 29 |
|
vital signs of blood pressure |
initial dose up to day 29 |
|
Vital signs of body temperature |
initial dose up to day 29 |
|
Vital signs of respiratory rate |
initial dose up to day 29 |
|
Number of Clinically significant changes in lab assessment of blood serum |
initial dose up to day 29 |
|
Number of Clinically significant changes in the lab assessment of blood |
initial dose up to day 29 |
|
Number of Clinically significant changes in the lab assessment of urine |
initial dose up to day 29 |
Enrollment
16
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
Dose 1
Arm Group Label
Combination Therapy
Eligibility
Criteria
Inclusion Criteria:
- Normal renal function at screening as evidenced by an estimated glomerular filtration
rate (GFR) > 80 mL/min/1.732 m2 calculated with the Chronic Kidney Disease
Epidemiology Collaboration formula.
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy
test (minimum sensitivity 25 IU/L or equivalent units of human chorionic onadotropin)
within 24 hours prior to the start of study treatment.
- Body mass index of 18.0 kg/m2 to 32.0 kg/m2, inclusive, and body weight ≥ 50 kg, at
screening.
Exclusion Criteria:
- Participants who currently smoke, as well as those who have stopped smoking less than
6 months prior to dosing on Day 1.
- Evidence of organ dysfunction or any clinically significant deviation from normal in
physical examination, vital signs, ECG, or clinical laboratory determinations beyond
what is consistent with the target population.
- Prisoners or participants who are involuntarily incarcerated
- Any significant acute or chronic medical condition that presents a potential risk to
the participant and/or may compromise the objectives of the study, including a history
of or active liver disease
Gender
All
Minimum Age
18 Years
Maximum Age
50 Years
Healthy Volunteers
Accepts Healthy Volunteers
Overall Official
Last Name |
Role |
Affiliation |
|
Bristol-Myers Squibb |
Study Director |
Bristol-Myers Squibb |
Location
Facility |
|
PRA Health Sciences - Salt Lake Salt Lake City Utah 84124 United States |
Location Countries
Country
United States
Verification Date
2019-10-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Has Expanded Access
No
Number Of Arms
1
Intervention Browse
Mesh Term
Ritonavir
Arm Group
Arm Group Label
Combination Therapy
Arm Group Type
Experimental
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Intervention Model
Single Group Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)
Study First Submitted
August 9, 2019
Study First Submitted Qc
August 12, 2019
Study First Posted
August 13, 2019
Last Update Submitted
October 21, 2019
Last Update Submitted Qc
October 21, 2019
Last Update Posted
October 23, 2019
ClinicalTrials.gov processed this data on December 06, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.